United Therapeutics Corp. said the U.S. Food and Drug Administration approved the inclusion of new data from a late-stage study to the label of hypertension drug Orenitram.
The updated label will indicate that Orenitram, or treprostinil, in extended-release tablets delays disease worsening when used with an approved oral background therapy for pulmonary arterial hypertension, the Silver Spring, Md.-based company said.
Patients with pulmonary arterial hypertension experience high blood pressure in the blood vessel that carries blood from the heart to the lungs. This can lead to chest pain, fatigue and eventual heart failure.
Results from the study, called Freedom-EV, showed patients treated with Orenitram had a 26% lesser risk of experiencing a clinical worsening event, compared to their placebo-treated counterparts. The company said this was largely driven by delay in disease progression, the risk for which Orenitram cut by 61%, compared to placebo.
The FDA originally approved Orenitram in 2013, with a label indicating that Orenitram, when used as a single therapy, improves the capacity of patients with pulmonary arterial hypertension to exercise.
In the U.S., pulmonary hypertension is more common among women, non-Hispanic blacks, and among people aged 75 or older, according to the Centers for Disease Control and Prevention.